Components of
Participating Organizations
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)

Title:International Research on Venue-Based Interventions for HIV/AIDS and Alcohol
Use (R21)

Announcement Type
New

Request For
Applications (RFA) Number:RFA–AA-08-012

NOTICE: Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter
called Grants.gov/Apply).

A registration process is necessary before submission and
applicants are highly encouraged to start the process at least four weeks prior
to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.273

Key Dates
Release/Posted Date: February 26, 2008
Opening Date: April 9, 2008 (Earliest date an application may be
submitted to Grants.gov) Letters
of Intent Receipt Date(s): April 9, 2008 NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization). ApplicationSubmission/Receipt
Date(s): May 9, 2008Peer Review Date(s): June/July, 2008Council Review Date(s): August, 2008Earliest Anticipated Start Date(s): September 1, 2008Additional Information To
Be Available Date (Activation Date):Not ApplicableExpiration Date: May 10, 2008

Due Dates for E.O. 12372

Not
Applicable

Additional
Overview Content

Executive Summary

Purpose.This funding opportunity
announcement (FOA) issued by the National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health solicits Research Project (R21) grant
applications from applicant organizations that propose to conduct collaborative
international research on alcohol abuse and HIV/AIDS, with a specific focus on
research that examines the impact of environmental factors on concurrent
drinking and high risk sexual behavior.

Mechanism of Support.This
FOA will utilize the R21 grant mechanism and runs in parallel with a FOA of
identical scientific scope, RFA-AA-08-011,
that solicits applications under the R01 mechanism.

Funds Available and
Anticipated Number of Awards. NIAAA intends to commit up to a total of $3 million in FY 2008 to
support meritorious projects that are responsive to this FOA (RFA-AA-08-012)
and the companion FOA (RFA-AA-08-011).
Awards issued under this FOA are contingent upon the availability of funds and
the submission of a sufficient number of meritorious applications.

Budget and Project Period.Direct costs are limited to $275,000 over a
two-year period, with no more than $200,000 in direct costs allowed in any
single year. Applicants may request costs in $25,000 modules, up to the total
direct cost limitation of $275,000 for the combined two-year period. All foreign applicants must complete and submit
detailed budget requests using the Research & Related Budget component
found in the application package.

Eligible
Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with
their institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

Number
of PDs/PIs. More than one PD/PI
(i.e., multiple PDs/PIs) may be designated on the application.

Number
of Applications. Applicants may
submit more than one application, provided each application is
scientifically distinct.

Resubmissions. Resubmission applications are not
permitted in response to this FOA.

Renewals. Renewal
applications are not permitted in response to this FOA.

The intent of
this FOA issued by the National Institute on Alcohol Abuse and Alcoholism
(NIAAA) is to stimulate research, particularly collaborative efforts between US
and foreign investigators, to investigate alcohol-related aspects of risks for
HIV transmission and infection. The primary focus of this announcement is to
develop and test new interventions, which may also include exploratory
descriptive studies that lead to the development of venue-based interventions.
There is considerable epidemiological evidence linking alcohol-related high
risk sexual behavior with HIV and other sexually transmitted infections.
Ethnographic research has provided rich descriptions of social, cultural, and
economic contexts in which people engage in alcohol-related sexual risk
behaviors. More specifically, alcohol use characteristics (e.g., binge
drinking, episodic drinking, etc.) have been linked with sexual risk-taking
that occurs in a range of high risk environments. Recent reviews of the
epidemiological literature from studies done in Africa have shown that heavy
alcohol users were more likely to be HIV+. Problem drinkers were twice as
likely to be HIV+ when compared with non-problem drinkers. Yet few
interventions explicitly address the contribution of alcohol use to
co-occurring high risk sexual or drug use behavior. Instead, alcohol
consumption often is subsumed under the category of a generic “trigger” for
behavioral risk, while limited attention is given to the unique contextual or
motivational aspects of alcohol use which may influence sexual and drug use HIV
risk behavior.

This FOA seeks to explore alternative strategies for
developing and testing interventions that are ecologically sound and address
the role of alcohol in increasing HIV risk behaviors in geographically
identified contexts. Alcohol use settings and aggregate risks found within
these settings have been implicated as a focus for converging social, substance
abuse, and sexual networks. There is a need for further research to further
extend the understanding of environmental facilitators of risk for HIV
infection within these settings and locations, which are often in urban areas
which draw men and women for employment. Populations engaging in high risk
sexual behaviors consequent to alcohol use, particularly heavy episodic or
binge drinking, can include, but are not limited to, male bar patrons and their
sex partners; male and female commercial sex workers and clients; transport
corridor workers (e.g., long distance truck drivers, merchant marines, etc.);
fishermen; and employed military personnel, among others.

Recent reviews of the literature from research conducted
in Africa, Russia and India have described the strong relationship between alcohol
use, sexual risk taking, and the risk for HIV infection, focusing on behaviors
such as having multiple, concurrent sex partners and having unprotected sex.
In wine shop settings in India it was observed that over 50% of patrons
reported 3 or more partners in the last 3 months and 71% reported a history of
exchanging sex for money and low rates of condom use. In addition, the lowest
use of condoms was among those who reported drinking to feel disinhibited and
those having expectancies that alcohol use would enhance sexual activity. These
findings and other similar findings suggest that certain specific settings may
be appropriate targets for interventions which incorporate knowledge of alcohol
use effects within these contexts. Interventions targeting the unique
contextual cues that impel or inhibit drinking and unsafe sex may be of
particular interest.

Settings

Locations where high risk sexual behaviors are initiated
(high risk venues) include formal and informal drinking establishments in both
urban and rural areas. They often exist along frequently traveled routes or
near borders where populations mix. These locations may include bars,
“shabeens” (home-brew or unlicensed sales points); migrant worker settlements;
commercial sex establishments such as brothels or massage parlors; circuit
parties; bathhouses (the latter two venues are increasingly common in SE Asia
and are contributing to the growing epidemic among MSM there); truck stops; bus
terminals or ports; border towns; and high risk work settings, in particular
those which involve alcohol production (e.g., shabeens). Bars and other
drinking venues where alcohol is consumed and sexual mixing occurs are ideal
settings in which to implement HIV prevention programs. Such programs may
deliver a range of evidence-based, low-cost, feasible, public health
interventions that can reach persons and social networks engaged in high risk
sexual behaviors.

Other formal or informal health care venues (e.g., STI
clinics and substance abuse treatment programs, emergency rooms, and indigenous
health care provider practice settings, etc.) may also provide critical
opportunities to identify individuals who engage in both at-risk drinking and
high risk sexual and drug use behaviors. These individuals may be highly receptive
to advice regarding alcohol use and sexual risk behavior during “teachable
moments” (e.g., advice regarding ways to reduce risk of re-infection with
sexually transmitted pathogens, including reducing visits to high risk venues
such as circuit parties, etc.).

Additional Issues: Limitations of Past Interventions

In the past randomized controlled trials based on
Information Motivational Behavioral (IMB) models have dominated community-based
interventions targeting individuals who engage in HIV risk behaviors, and, to a
lesser extent, those with alcohol use disorders. These rational
cognitively-focused models have also dominated addiction treatment in clinical
contexts. However, recent research on these interventions has defined the
limits of these intense client-centered approaches to changing behavior, often
finding only a modest treatment effect. While Motivational Interviewing,
Cognitive Behavioral Therapy, Behavioral Couples’ Therapy, and Twelve
Step-oriented treatments have been applied in both HIV and alcohol abuse areas,
reviews of the research on these interventions have suggested that more
impelling situational cues, particularly in the context of substance use, and
situational control factors often undermine intended long-term behavior change
and prevention practices. These factors may be particularly important
determinants of the level of negotiated risk among women, since women are often
unable to control male condom use. This solicitation strongly encourages
research on novel interventions that incorporate knowledge of venue-specific
factors that may influence sex and drug-related decision-making in the targeted
population.

A specific focus of this research should be on how
specific environmental contexts (bars, etc.) affect intervention targets such
as cognitions or implementation of behavior skills. Creative use of a wide
range of research methodologies is encouraged, including combining qualitative
and quantitative methods. In addition, investigators are encouraged to
consider how theories of behavior change can be applied to the unique contexts
described above. A number of setting-specific strategies to promote behavior
change that reduces the risk of HIV infection among individuals with alcohol
use disorders have been suggested. These contextualized interventions broadly
distributed in the environment may prove to be a more comprehensive and
effective approach that begins to acknowledge the important impact that
specific venues may have on high risk sexual and alcohol use behavior.

It is important to note that prior research has
demonstrated the limited effectiveness of modest modifications of interventions
for a single behavior to address co-occurring drinking and unsafe sex. It
seems likely, therefore, that modest adaptations of existing interventions will
have only a limited public health impact. Exploratory efforts are needed to
understand the specific contextual cues and sequence of causal pathways that
link alcohol use to HIV risk behavior, as well as to identify which of those pathways
can be effectively changed using innovative counseling techniques or other
interventions. Accordingly, one purpose of the R21 is to provide investigators
with an opportunity to conduct theory-driven formative research that moves
beyond technical modifications of existing strategies to fully developed, novel
interventions.

New Approaches to Developing and Testing Interventions

Different community- and individual-level approaches to
developing interventions for people with alcohol use disorders have at times
acknowledged the importance of physical or venue-based interventions, but have
not in general incorporated more comprehensive, integrated or multilevel
strategies (e.g., an approach that simultaneously targets individual bar
patrons, alcohol servers, and alcohol policy-makers, etc.). It is important
that addiction and HIV researchers explore new ways to examine and impact the
full range of settings where substances, in particular alcohol, may influence
HIV transmission, particularly in international settings where intensive
psychotherapy and other individual-level approaches are not feasible or are
unlikely to be effective.

Venue-based research draws on the increased ability to map
the larger physical environment, social networks, and HIV-risk behaviors of
individuals who engage in problem drinking within these environments.
Developing complete community-level maps of risk and potential intervention
venues such as bars and night clubs could lead to an “ecological understanding”
of risk and how it is distributed in time and space. It may thus both increase
the ability to predict the rate of spread of HIV and suggest critical
intervention points in this larger context.

The use of the R21 Exploratory/Developmental grant
mechanism will allow maximum flexibility for investigators to develop new
collaborations or build upon existing collaborations to conduct exploratory,
developmental studies addressing any of a number of research questions. (See
below.) It is anticipated that the data collected and knowledge gained will
stimulate new R01 and other applications.

Areas of Interest

The purpose of this NIH research program is to increase
research on alcohol-related HIV risk that will inform interventions to reduce
sexual risk-taking among patrons of formal or informal drinking establishments
and among patients in a variety of alcohol treatment settings, including but
not limited to emergency rooms and alcohol treatment programs. It is
ultimately intended to provide the scientific foundation upon which governments
may build effective and far-reaching HIV prevention programs that will stem the
tide of the epidemic. The program expands and enhances past NIAAA activities in
the area of alcohol and HIV/AIDS prevention and other related areas, including
research on server training, safe rides programs, brief interventions in a
variety of contexts, and social/structural interventions shown to be effective
in reducing alcohol-related morbidity and mortality.

In addition, NIAAA recognizes that there are ongoing alcohol
and HIV/AIDS interventions that may benefit from increased research capacity.
The proposed research-tested interventions will be designed to strengthen the
capacity of public health agencies, non-government (NGO), and community-based
(CBO) organizations to: 1) engage bar owners, operators of informal drinking
establishments, and other personnel associated with drinking venues, who will
be instrumental in providing access and a supportive environment in which to
carry out interventions; and 2) develop and implement venue-based,
appropriately tailored public health interventions targeting specific
populations or sub-populations at increased risk of HIV infection because of
their drinking and sexual risk behaviors; and 3) measure structural,
behavioral, and biological outcomes (e.g., adoption of programs, norm changes,
and HIV/STD incidence).

Potential Partners

NIAAA recognizes that there may be special opportunities
in different regions of the world to address particular questions of interest.
The questions below are examples of universal and region-specific research
questions that are of interest. The inclusion of region-specific areas of
interest is meant to encourage research that has the potential to ultimately
lead to regional research networks that address HIV/AIDS.

Venue-based interventions may be carried out in
collaboration with existing intervention sites such as those supported by the
Centers for Disease Control and the Office of the Global AIDS Coordinator –
President’s Emergency Plan for AIDS Relief (OGAC-PEPFAR). Such programs may
already include interventions based on delivery of informational materials;
outreach and delivery of risk reduction messages to patrons; scheduled “events”
such as skills-based training (e.g. condom use); condom distribution; on-site
HIV counseling and testing; referral to HIV/AIDS care and treatment services;
STI testing for commercial sex workers; services targeting pregnant women for
the prevention of mother to child transmission; and peer-educator interventions.
However, adequate research measurement to assess a variety of outcomes and to
assure fidelity of approach and quality of the data must be included.

Specific outcomes of interest include but are not limited
to:

1. Increased knowledge and awareness of the strong
relationship between alcohol use, sexual risk taking, and the risk for HIV
infection among patrons, owners, managers, and other persons who frequent
alcohol establishments. Identification of effective approaches to reducing
high risk sexual behaviors associated with these venues.

2. Increased knowledge and
awareness of the strong relationship between alcohol use, sexual risk taking,
and the risk for HIV infection in medical and other clinical settings,
including but not limited to STI clinics, emergency rooms, and other formal and
informal health care delivery settings. Identification of effective approaches
to delivering alcohol and HIV/AIDS interventions in these settings.

3. Increased knowledge and
awareness of the strong relationship between alcohol use, sexual risk taking,
and the risk for HIV infection in other high risk community settings (e.g.,
truck stops, brothels, bathhouses, etc.), including development of measures
that address use of alcohol in partner selection and involvement in high risk
sexual behavior. Identification of effective approaches to reducing high risk
sexual behaviors associated with these settings.

4. Determination of best
approaches to using rapid HIV testing methodology supported by the CDC to
determine HIV status, or other appropriate biological outcomes where possible,
and to carrying out cross-sectional sampling of regional populations.
Determine feasibility of HIV testing among alcohol users and their partners in
identified settings like bars, bathhouses, and circuit parties. (There already
have been efforts in Asia to do testing in circuit party settings, and
bathhouse-based testing is very common in the US.)

5. Development of new
measurement methodologies, including adequate tests of intervention “stopping
points” at which sufficient data has been collected to support modifying or
discontinuing strategic interventions. Measurement of implementation impact.
Examples of innovative methodologies might include but not be limited to small
sample designs that would enable detailed exploration of intervention uptake
and outcome under different scenarios of dosage, modality, etc. Another example
would be the development of new approaches to measuring alcohol use and HIV
risk behavior in situ or at other points where recall will be most reliable.
This will be more practical in countries where new alcohol use indicators
(transdermal patch) are widely available and easily adopted. Simpler methods
like counting patrons, collecting beer bottles, and collecting used condoms in a
brothel setting could be done in reduced resource settings.

6. Development of new
theoretical and modeling approaches that are based on person x environment
interactions, including models that map physical, social, and temporal
dimensions of risks distributed within the environment as a result of alcohol
use (e.g., liquor outlets). This modeling may be approached in several
different ways; e.g., the modeling could be non-quantitative and based more on
obtaining scripts or ethnographic observations of settings; or it could be
based on asset (social capital) mapping or mapping daily routes and activities
of individuals to form comprehensive risk profiles (e.g., mapping as part of a
rapid policy assessment after implementation of a structural intervention, etc.).

7. We encourage
applications that are adjuncts to existing trials to address measurement and
assessment issues, as well as novel evaluation methods. The goal is to promote
descriptive research that may inform the development of effective
interventions.

Global/Universal Questions:

• How can alcohol risk
reduction interventions better address situations where alcohol use contributes
to HIV sexual risk behavior among HIV+ individuals? How can alcohol treatment
and outreach programs be adapted and improved to reduce alcohol-related high
risk sexual behaviors?

• How can interventions
to identify alcohol use disorders or reduce problem drinking be integrated into
STD clinic environments?

• How can practitioners
in settings that see problem drinkers (e.g., primary care clinics, STD clinics,
etc.) be trained to provide alcohol assessment, referral for treatment, and
brief interventions to reduce alcohol consumption?

• How can interventions
for problem drinking be effectively implemented in settings where alcohol is
served or consumed and where people seek sexual partners? The business
practices and potential roles of staff in these establishments (e.g.,
bartenders, sex workers, etc.) should be considered.

• How can media-based
interventions to reduce alcohol-related HIV risk behaviors be implemented in
settings where alcohol is served or consumed and where people seek sexual
partners, including small media, interactive video, role model stories
delivered by various media, etc.?

• What measurement
methodologies and paradigms from the study of environments can be applied to
HIV prevention in alcohol-related venues (e.g., behavior setting measurement,
rapid ethnographic assessment, etc.) and used for outcome and process
evaluation in intervention studies?

• How can behavioral
assessment methodologies (e.g., diary methods, applied behavior analysis, etc.)
be adapted for evaluation of HIV risk and alcohol use in interventions
conducted in alcohol-related venues?

• How can HIV
testing/counseling/prevention/referral for care take advantage of the unique
features of alcohol treatment settings, including both inpatient and outpatient
settings?

• How can HIV testing and
counseling be promoted in settings where alcohol use and HIV sexual risk
behavior are common, such as bathhouses and circuit parties?

• How may we better
understand the intersection between alcohol use and abuse and commercial and
transactional sex? “Transactional sex” refers to less overtly commercial
transactions where exchanges of money, goods, and services for sex occurs. How
may enhanced information about the role of alcohol in commercial and
transactional sex be used to develop effective HIV preventive interventions?

• How can messages about
individual survival and the effects of viral resistance factors on disease
progression, complications (such as liver damage), and response to antiretroviral treatment be framed in the context of
alcohol abuse/HIV risk reduction efforts in clinical and high risk community
settings (e.g., studies examining approaches to integrating such messages into
alcohol treatment programs or HIV treatment and service settings, etc.)?

• How can messages about
alcohol use disorders and comorbid psychiatric illnesses be framed to improve
clinical management of HIV/AIDS and co-morbid psychiatric conditions such as
depression in the setting of continued alcohol use and abuse. How can such
messages be integrated into risk reduction strategies in mental health or
substance use case management, HIV treatment settings, and AIDS service organizations?

• What interventions for
alcohol misuse and alcohol use disorders (including both behavioral and
pharmacological interventions) can be effectively employed in international
settings to reduce HIV acquisition and transmission among chronic and acute
alcohol users?

• What interventions to
reduce HIV acquisition and transmission (e.g., testing and counseling,
structural, outreach, etc.) can be effectively employed in international
settings to reduce HIV transmission among chronic and acute alcohol users,
especially given that these individuals often have poor access to VCT and
treatment and/or fail medication regimens prematurely?

• What is the
cost-effectiveness of interventions that may be implemented in alcohol-related
venues to reduce HIV/AIDS morbidity and mortality?

• What are the best
approaches to integrating HAART and interventions for problem drinking in
specific venues?

• How do policies
established by commercial sex establishment owners or regulatory bodies
involved with alcohol affect alcohol consumption, HIV risk behavior, and the
ways in which alcohol is used in conjunction with sexual risk behavior?

• How can HIV-related
services, including strategies to improve adherence to HAART, be adapted to
address the needs of drinkers in specific alcohol-related venues (e.g., bars,
etc.)?

• How can effective HIV
prevention interventions be developed for sex workers who engage in at-risk
drinking?

• How does culture
influence the interaction between alcohol and HIV risk behavior in specific venues?

• How can prevention and
treatment interventions for problem drinking be integrated with established
venue-based HIV prevention approaches to optimize their combined effectiveness?
What institutional changes would need to take place to allow for this integration?

This FOA will use the R21 award mechanism. The Project Director/Principal
Investigator (PD/PI) will be solely responsible for planning, directing, and
executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also
uses the modular as well as the non-modular budget formats (see the “Modular
Applications and Awards” section of the NIH
Grants Policy Statement. Specifically, if you are submitting an
application with direct costs in each year of $250,000 or less (excluding
consortium Facilities and Administrative [F&A] costs), use the PHS398
Modular Budget component provided in the SF424 (R&R) Application Package
and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular
Budget Component,” of the Application Guide).

All Foreign applicants must complete and submit
budget requests using the Research & Related Budget component.

2. Funds Available

The participating organization, NIAAA, intends to commit approximately 3
million dollars in FY2008 to fund 10-12 applications. It is anticipated that
interventions will be identified within 5 to 7 different countries. These
activities may be coordinated by NIAAA through a variety of cooperative
mechanisms in order to assure comparable outcome measures for interventions.
Costs may include: (1) development of specific intervention materials; (2)
travel and consultation fees for experts conducting research and follow-up
measurement; (3) participant travel to study sites; (4) program support to add
the intervention component to existing programs; and (5) translation,
monitoring, and evaluation of outcome measures.

Budget: The total projected period for an
application submitted in response to this funding opportunity may not exceed 2
years. Although the size of the award may vary with the scope of the research
proposed, it is expected that the applications will stay within the budgetary
guidelines for an exploratory/developmental project. Direct costs are limited
to $275,000 over a two-year period, with no more than $200,000 in direct costs
allowed in any single year. Applicants may request costs in $25,000 modules, up
to the total direct cost limitation of $275,000 for the combined two-year
period.

Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the ICs provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications.

NIH
grants policies as described in the NOT-OD-05-004,
November 2, 2004.

Any individual with the skills,
knowledge, and resources necessary to carry out the proposed research as the
Project Director/Principal Investigator (PD/PI) is invited to work with his/her
organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

More than one PD/PI or multiple PDs/PIs
may be designated on the application for projects that require a “team science”
approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and
procedures to formally allow more than one PD/PI on individual research
projects is available at https://grants.nih.gov/grants/multi_pi. All PDs/PIs
must be registered in the NIH eRA Commons prior to
the submission of the application. (See
http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a
single PD/PI or multiple PD/PI grant is the responsibility of the investigators
and applicant organizations and should be determined
by the scientific goals of the project. Applications for multiple PD/PI grants
will require additional information, as outlined in the instructions below. The
NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving
either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs,
please be aware that the structure and governance of the PD/PI leadership team
as well as the knowledge, skills, and experience of
the individual PD/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share the
authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization or, as appropriate, to
a collaborating organization for the proper conduct of the project or program,
including the submission of required reports. For further information on multiple PDs/PIs, please see
https://grants.nih.gov/grants/multi_pi.)

Applicants are not permitted to submit a resubmission
application in response to this FOA.

Renewal applications are not permitted in
response to this FOA.

Applicants may
submit more than one application, provided each application is scientifically
distinct.

Section
IV. Application and Submission Information

To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, use the “Apply for Grant Electronically” button in this FOA or link
to http://www.grants.gov/Apply/ and follow the directions provided on that Web
site.

A one-time registration is required for
institutions/organizations at both:

The individual(s) designated as PDs/PIs on the
application must be registered also in the NIH eRA Commons. In the case of
multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in
the eRA Commons prior to the submission of the application.

Each PD/PI must hold a PD/PI account in the
Commons. Applicants should not share a Commons account for both an Authorized
Organization Representative/Signing Official (AOR/SO) role and a PD/PI role;
however, if they have both a PD/PI role and an NIH Internet Assisted Review
(IAR) role, both roles should exist under one Commons account.

When multiple PDs/PIs are proposed, all
PDs/PIs at the applicant organization must be affiliated with that
organization. PDs/PIs located at another institution need not be affiliated
with the applicant organization, but must be affiliated with their own
organization to be able to access the Commons.

This registration/affiliation must be done by
the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate accounts in
the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer reviewer with an
Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than any
DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to the
Federal Government.

Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their organization/institution is
already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.

Prepare all applications using the SF424 (R&R)
application forms and in accordance with the SF424
(R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application
Guide is critical to submitting a complete and accurate application to NIH.
There are fields within the SF424 (R&R) application components that,
although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic Submission
of Grant Applications.”

The SF424 (R&R) application is comprised of data
arranged in separate components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYwill include all
applicable components, required and optional. A completed application in
response to this FOA will include the following components:

Proposed
research should provide special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

The intent
of this FOA is to encourage collaborative research proposals. Consequently,
investigators are encouraged to submit applications with Multiple PDs/PIs.

SPECIAL INSTRUCTIONS

Applications
with Multiple PDs/PIs

When multiple PDs/PIs are proposed,
NIH requires one PD/PI to be designated as the "Contact” PI, who will be
responsible for all communication between the PDs/PIs and the NIH, for
assembling the application materials outlined below, and for coordinating
progress reports for the project. The contact PD/PI must meet all eligibility
requirements for PD/PI status in the same way as other PDs/PIs, but has no
other special roles or responsibilities within the project team beyond those
mentioned above.

Information for the Contact PD/PI
should be entered in item 15 of the SF424(R&R) Cover component. All
other PDs/PIs should be listed in the Research & Related Senior/Key Person
component and assigned the project role of “PD/PI.” Please remember that
all PDs/PIs must be registered in the eRA Commons prior to application
submission. The Commons ID of each PD/PI must be included in the
“Credential” field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

All projects proposing Multiple PDs/PIs will be
required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research
plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research
Plan Component in the SF424 (R&R)), must be included. A rationale for
choosing a multiple PD/PI approach should be described. The governance and organizational
structure of the leadership team and the research project should be described,
including communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution
of resources to specific components of the project or the individual PDs/PIs should
be delineated in the Leadership Plan. In the event of an award, the requested
allocations may be reflected in a footnote on the Notice of Award.

Applications
Involving a Single Institution

When all PDs/PIs are within a
single institution, follow the instructions contained in the SF424 (R&R)
Application Guide.

Applications Involving Multiple
Institutions

When multiple institutions are
involved, one institution must be designated as the prime institution and
funding for the other institution(s) must be requested via a subcontract to be
administered by the prime institution. When submitting a detailed budget, the
prime institution should submit its budget using the Research & Related
Budget component. All other institutions should have their individual
budgets attached separately to the Research & Related Subaward Budget
Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application
Guide for further instruction regarding the use of the subaward budget
form.

When submitting a modular budget, the
prime institution completes the PHS398 Modular Budget component
only. Information concerning the consortium/subcontract budget is provided
in the budget justification. Separate budgets for each consortium/subcontract
grantee are not required when using the Modular budget format. See Section 5.4
of the Application Guide for further instruction regarding the use of the
PHS398 Modular Budget component.

Prospective applicants are asked
to submit a letter of intent that includes the following information:

Descriptive
title of proposed research.

Name,
address, and telephone number of the PD/PI.

Names
of other key personnel.

Participating
institutions.

Number
and title of this funding opportunity.

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are
requested to notify the NIAAAReferral
Office by email at bautista@mail.nih.gov when the application has been
submitted. Please include the FOA number and title, PD/PI name, and
title of the application.

3.C.
Application Processing

Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.

Once an application package has been successfully
submitted through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the Authorized
Organization Representative/Signing Official (AOR/SO) have two business days to
view the application image.

If everything is acceptable, no
further action is necessary. The application will automatically move forward
for processing by the Division of Receipt and Referral, Center for Scientific
Review, NIH, after two business days.

Prior to the submission deadline,
the AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This option
should be used if the AOR/SO determines that warnings should be addressed.
Reminder: warnings do not stop further application processing. If an
application submission results in warnings (but no errors) it will
automatically move forward after two business days if no action is taken.
Please remember that some warnings may not be applicable or may need to be addressed
after application submission.

If the two-day window falls after
the submission deadline, the AOR/SO will have the option to “Reject” the
application if, due to an eRA Commons or Grants.gov system issue, the
application does not correctly reflect the submitted application package (e.g.,
some part of the application was lost or didn’t transfer correctly during the
submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the
system error, document the issue, and determine the best course of action. NIH
will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject”
the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted,
but it will be subject to the NIH late
policy guidelines and may not be accepted. The reason for this delay should
be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will
receive e-mail notifications when the application is rejected or the
application automatically moves forward in the process after two days.

Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on their application
status in the Commons.

The NIH will not accept any
application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.

All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.

Pre-award costs are allowable. A grantee may, at
its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project. See
the NIH Grants
Policy Statement.

6. Other Submission
Requirements

PD/PI
Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential”
log-in field of the “Research & Related Senior/Key Person Profile”
component. The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional information,
see “Registration FAQs – Important Tips -- Electronic
Submission of Grant Applications.”

Organizational DUNS

The applicant organization must
include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions –
Application Guide, Electronic
Submission of Grant Applications.”

PHS398 Research Plan Component Sections

While each section of the
Research Plan component needs to be uploaded separately as a PDF attachment,
applicants are encouraged to construct the Research Plan component as a single
document, separating sections into distinct PDF attachments just before
uploading the files. This approach will enable applicants to better monitor
formatting requirements such as page limits. All attachments must be provided
to NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

R21 applications will use the modular as well as the non-modular budget formats and "Just-in-Time" information concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period. No more than $200,000 in direct costs will be allowed in any single year.

Items 2-5 of the Research Plan component of the R21 application may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.

Introduction (required for a resubmission application) is limited to one page.

Do not use the Appendix to circumvent the page
limitations of the Research Plan component. An application that does not comply
with the required page limitations may be delayed in the review process.

Resource
Sharing Plan(s)

NIH considers the sharing of
unique research resources developed through NIH-sponsored research an important
means to enhance the value and further the advancement of the research. When
resources have been developed with NIH funds and the associated research
findings published or provided to NIH, it is important that they be made
readily available for research purposes to qualified individuals within the
scientific community. If the final data/resources are
not amenable to sharing, this must be explained in the Resource Sharing section
of the application (see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(b) Sharing Model Organisms: Regardless of
the amount requested, all applications in which the development of model
organisms is anticipated are expectedto include a description of
a specific plan for sharing and distributing unique model organisms and related
resources, or state appropriate reasons why such sharing is restricted or not
possible (see Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.)

(c) Genome-Wide
Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a
genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designatedGWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as
any study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (e.g., blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies(NOT-OD-07-088) and https://grants.nih.gov/grants/gwas/.

Foreign
Applications (Non-Domestic [non-U.S.] Entities)

Indicate
how the proposed project has specific relevance to the mission and objectives
of the NIH/IC and has the potential for significantly advancing the health
sciences in the United States.

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

2. Review and
Selection Process

Applications that are complete and responsive to
this FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by NIAAA and
in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the scientific peer
review, all applications will:

Undergo a selection
process in which only those applications deemed to have the highest
scientific and technical merit, generally the top half of applications
under review, will be discussed and assigned a priority score;

Receive a written
critique; and

Receive a second level of
review by the NIAAA National Advisory Council

Applications submitted in response
to this FOA will compete for available funds with all other recommended
applications submitted in response to this FOA. The following will be
considered in making funding decisions:

Scientific merit of the
proposed project as determined by peer review.

Availability of funds.

Relevance of the proposed
project to program priorities.

The goals of NIH supported research are to advance
our understanding of biological systems, to improve the control of disease, and
to enhance health. In their written critiques, reviewers will be asked to
comment on each of the following criteria in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit of these
goals. Each of these criteria will be addressed and considered in assigning the
overall score, and weighted as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a meritorious priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Significance:Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Approach:Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? For applications
designating multiple PDs/PIs, is the leadership approach, including the designated
roles and responsibilities, governance, and organizational structure,
consistent with and justified by the aims of the project and the expertise of
each of the PDs/PIs?

Innovation: Is the project original and innovative? For
example: Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area?

Investigators:Are the
PD(s)/PI(s) and other key personnel appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers? Do(es) the PD(s)/PI(s) and
investigative team bring complementary and integrated expertise to the project
(if applicable)?

Environment: Do(es) the
scientific environment(s) in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:

Protection of Human Subjects
from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See the “Human Subjects Sections” of the PHS398 Research Plan
component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research
Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the “Other Research Plan Sections” of the PHS398 Research
Plan component of the SF424 (R&R).

Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.

Applications from Foreign
Organizations: Whether the project presents special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not
readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing
Plan(s)

When relevant,
reviewers will be instructed to comment on the reasonableness of the following
Resource Sharing Plans, or the rationale for not sharing the following types of
resources. However, reviewers will not factor the proposed resource sharing
plan(s) into the determination of scientific merit or priority score, unless
noted otherwise in the FOA. Program staff within the IC will be responsible for
monitoring the resource sharing.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”

A final progress
report, invention statement, and Financial Status Report are required when an
award is relinquished when a recipient changes institutions or when an award is
terminated.

Section
VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
financial or grants management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):NIH is
interested in advancing genome-wide association studies (GWAS) to identify
common genetic factors that influence health and disease through a centralized
GWAS data repository. For the purposes of this policy, a genome-wide
association study is defined as any study of genetic variation across the
entire human genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight), or the presence or
absence of a disease or condition. All applications, regardless of the amount
requested, proposing a genome-wide association study are expected to provide a
plan for submission of GWAS data to the NIH-designated GWAS data repository, or
provide an appropriate explanation why submission to the repository is not
possible. Data repository management (submission and access) is governed by the
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see https://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And
Minorities in Clinical Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as
Participants in Clinical Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (https://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the
Protection of Human Subject Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells
(hESC):Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy
Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH
must submit or have submitted for them to the National Library of Medicine’s
PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic
version of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the
official date of publication. The NIH Public Access Policy is
available at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For
more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of
Individually Identifiable Health Information:The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications
or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. For publications listed in
the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles. Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.